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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in pharmacovigilance and aggregate safety report authoring, with strong analytical skills to interpret scientific data and collaborate effectively across cross-functional teams. Proven ability to manage projects and improve processes related to safety signal management and regulatory compliance.
Highest-signal resume keywords
Pharmacovigilance ExperienceAggregate Safety Reports WritingSafety Signal ManagementProject ManagementCollaboration Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Aggregate Safety Reports AuthoringData AnalysisMedical TerminologyClinical JudgmentProcess Improvement
Soft Skills
Strong Organizational SkillsAbility to Prioritize IndependentlyCollaborative Skills
Tools & Technologies
EXCELPowerPointMicrosoft WordBusiness ObjectsSafety Database Systems
Certifications & Qualifications
Bachelor’s Degree in Biologic or Natural ScienceAdvanced Degree (MSc, PhD, MPH, PharmD)
Industry Keywords
PharmacovigilanceDrug DevelopmentClinical Trial RegulationsPost-Marketing Safety RegulationsAggregate Reports Master Schedule
About the role
Key responsibilities & impact- Lead and conduct, independently and/or collaboratively, all aspects of authoring and project management of aggregate safety reports
- Serve as a subject matter expert on safety requirements and pharmacovigilance activities in cross-functional forums
- Support the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews
- Conduct worldwide legislation reviews related to aggregate reports and provide impact assessments
- Assist in authoring responses to safety questions from regulatory authorities with stakeholders
- Contribute to process improvement and consistency regarding aggregate reports and signal management
- Support implementation and maintenance of new and existing processes
- Interpret, analyze, and present scientific and medical data in verbal and written formats
- Collaborate with internal teams and external colleagues across Safety, Clinical Development, and other functions
- Apply clinical judgment to interpret case information and guide staff in interpretation
Requirements
What you’ll need- Bachelor’s Degree in biologic or natural science
- Minimum 5 years of pharmacovigilance experience, including aggregate safety reports writing and safety signal management
- Familiarity with pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations
- Strong organizational skills and ability to prioritize independently
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects)
- Knowledge of common safety database systems
- Advanced degree (MSc, PhD, MPH, PharmD, etc.)
- Advanced understanding of medical concepts and terminology
- Demonstrated authoring experience within pharmacovigilance
- Strong collaborative skills within cross-functional teams
Benefits
Comp & perks- Short-term and long-term incentives, including cash bonus and equity incentive opportunities
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- Minimum of 15 days of paid vacation
- Additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation